13 research outputs found
Factors and situations influencing the value of patient preference studies along the medical product lifecycle: a literature review
Industry, regulators, health technology assessment (HTA) bodies, and payers are exploring the use of patient preferences in their decision-making processes. In general, experience in conducting and assessing patient preference studies is limited. Here, we performed a systematic literature search and review to identify factors and situations influencing the value of patient preference studies, as well as applications throughout the medical product lifecyle. Factors and situations identified in 113 publications related to the organization, design, and conduct of studies, and to communication and use of results. Although current use of patient preferences is limited, we identified possible applications in discovery, clinical development, marketing authorization, HTA, and postmarketing phases
Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US
Objectives: Patient preference information (PPI) is gaining recognition among the
pharmaceutical industry, regulatory authorities, and health technology assessment (HTA)
bodies/payers for use in assessments and decision-making along the medical product
lifecycle (MPLC). This study aimed to identify factors and situations that influence the
value of patient preference studies (PPS) in decision-making along the MPLC according
to different stakeholders.
Methods: Semi-structured interviews (n = 143) were conducted with six different
stakeholder groups (physicians, academics, industry representa
Patient Preferences in the Medical Product Life Cycle: What do Stakeholders Think? Semi-Structured Qualitative Interviews in Europe and the USA.
Background Patient preferences (PP), which are investigated in PP studies using qualitative or quantitative methods, are a
growing area of interest to the following stakeholders involved in the medical product lifecycle: academics, health technology assessment bodies,
Factors and situations influencing the value of patient preference studies along the medical product lifecycle: a literature review
Industry, regulators, health technology assessment (HTA) bodies, and payers are exploring the use of patient preferences in their decision-making processes. In general, experience in conducting and assessing patient preference studies is limited. Here, we performed a systematic literature search and review to identify factors and situations influencing the value of patient preference studies, as well as applications throughout the medical product lifecyle. Factors and situations identified in 113 publications related to the organization, design, and conduct of studies, and to communication and use of results. Although current use of patient preferences is limited, we identified possible applications in discovery, clinical development, marketing authorization, HTA, and postmarketing phases. This study can inform different stakeholders on how to conduct, assess, and use patient preference studies and on when to include patient preference studies in development plans
Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review.
Background: The inclusion of patient preferences (PP) in the medical product life cycle is a topic of growing
interest to stakeholders such as academics, Health Technology Assessment (HTA) bodies, reimbursement agencies,
industry, patients, physicians and regulators. This review aimed to understand the potential roles, reasons for using
PP and the expectations, concerns and requirements associated with PP in industry processes, regulatory benefitrisk assessment (BRA) and marketing authorization (MA), and HTA and reimbursement decision-making.
Methods: A systematic review of peer-reviewed and grey literature published between January 2011 and March
2018 was performed. Consulted databases were EconLit, Embase, Guidelines International Network, PsycINFO and
PubMed. A two-step strategy was used to select literature. Literature was analyzed using NVivo (QSR international).
Results: From 1015 initially identified documents, 72 were included. Most were written from an academic
perspective (61%) and focused on PP in BRA/MA and/or HTA/reimbursement (73%). Using PP to improve
understanding of patients’ valuations of treatment outcomes, patients’ benefit-risk trade-offs and preference
heterogeneity were roles identified in all three decision-making contexts. Reasons for using PP relate to the unique
insights and position of patients and the positive effect of including PP on the quality of the decision-making
process. Concerns shared across decision-making contexts included methodological questions concerning the
validity, reliability and cognitive burden of preference methods. In order to use PP, general, operational and quality
requirements were identified, including recognition of the importance of PP and ensuring patient understanding in
PP studies.
Conclusions: Despite the array of opportunities and added value of using PP throughout the different steps of the
MPLC identified in this review, their inclusion in decision-making is hampered by methodological challenges and
lack of specific guidance on how to tackle these challenges when undertaking PP studies. To support the
development of such guidance, more best practice PP studies and PP studies investigating the methodological
issues identified in this review are critically needed
Design, Conduct and Use of Patient Preference Studies in the Medical Product Life Cycle
Objectives: To investigate stakeholder perspectives on how patient preference studies
(PPS) should be designed and conducted to allow for inclusion of patient preferences in
decision-making along the medical product life cycle (MPLC), and how patient preferences
can be used in such decision-making.
Methods: Two literature reviews and semi-structured interviews (n = 143) with healthcare
stakeholders in Europe and the US were conducted; results of these informed the design
of focus group guides. Eight focus groups were conducted with European patients,
industry representatives and regulators, and with US regulators and European/Canadian
health technology assessment (HTA) representatives. Focus groups were analyzed
thematically using NVivo.
Results: Stakeholder perspectives on how PPS should be designed and conducted
were as follows: 1) study design should be informed by the research questions and patient
population; 2) preferred treatment attributes and levels, as well as trade-offs among
attributes and levels should be investigated; 3) the patient sample and method should
match the MPLC phase; 4) different stakeholders should collaborate; and 5) results from
PPS should be shared with relevant stakeholders. The value of patient preferences in
decision-making was found to increase with the level of patient preference sensitivity of
decisions on medical products. Stakeholders mentioned that patient preferences are hardly
used in current decision-making. Potential applications for patient preferences across
industry, regulatory and HTA processes were identified. Four applications seemed most
promising for systematic integration of patient preferences: 1) benefit-risk assessment
by industry and regulators at the marketing-authorization phase; 2) assessment of major contribution to patient care by European regulators; 3) cost-effectiveness analysis; and 4)
multi criteria decision analysis in HTA.
Conclusions: The value of patient preferences for decision-making depends on the level
of collaboration across stakeholders; the match between the research question, MPLC
phase, sample, and preference method used in PPS; and the sen
Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review
BACKGROUND: The inclusion of patient preferences (PP) in the medical product life cycle is a topic of growing interest to stakeholders such as academics, Health Technology Assessment (HTA) bodies, reimbursement agencies, industry, patients, physicians and regulators. This review aimed to understand the potential roles, reasons for using PP and the expectations, concerns and requirements associated with PP in industry processes, regulatory benefit-risk assessment (BRA) and marketing authorization (MA), and HTA and reimbursement decision-making. METHODS: A systematic review of peer-reviewed and grey literature published between January 2011 and March 2018 was performed. Consulted databases were EconLit, Embase, Guidelines International Network, PsycINFO and PubMed. A two-step strategy was used to select literature. Literature was analyzed using NVivo (QSR international). RESULTS: From 1015 initially identified documents, 72 were included. Most were written from an academic perspective (61%) and focused on PP in BRA/MA and/or HTA/reimbursement (73%). Using PP to improve understanding of patients' valuations of treatment outcomes, patients' benefit-risk trade-offs and preference heterogeneity were roles identified in all three decision-making contexts. Reasons for using PP relate to the unique insights and position of patients and the positive effect of including PP on the quality of the decision-making process. Concerns shared across decision-making contexts included methodological questions concerning the validity, reliability and cognitive burden of preference methods. In order to use PP, general, operational and quality requirements were identified, including recognition of the importance of PP and ensuring patient understanding in PP studies. CONCLUSIONS: Despite the array of opportunities and added value of using PP throughout the different steps of the MPLC identified in this review, their inclusion in decision-making is hampered by methodological challenges and lack of specific guidance on how to tackle these challenges when undertaking PP studies. To support the development of such guidance, more best practice PP studies and PP studies investigating the methodological issues identified in this review are critically needed
Factors and situations affecting the value of patient preference studies: semi-structured interviews in Europe and the US.
Objectives: Patient preference information (PPI) is gaining recognition among the
pharmaceutical industry, regulatory authorities, and health technology assessment (HTA)
bodies/payers for use in assessments and decision-making along the medical product
lifecycle (MPLC). This study aimed to identify factors and situations tha